HIGH

Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.

Quick Facts at a Glance

Recall Date
April 14, 2026
Hazard Level
HIGH
Brands
MONSELS SOLUTION, Premier Dental Products Company
Geographic Scope
1 states

Hazard Information

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Premier Dental Products Co or your healthcare provider for guidance. Notification method: E-Mail

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Full Description

Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.. Generic: FERRIC SUBSULFATE; Brand: MONSELS SOLUTION. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.. Classification: Class III. Quantity: 573 cartons. Distribution: Nationwide within the United States

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot #: 640911253
Exp Date. 09/14/2027.
UPC Codes
48783-112
48783-112-08
Affected States
ALL
Report Date
April 29, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE